Monograph: Flaxseed

Help on accessing alternative formats, such as Portable document format (PDF), Microsoft word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-09-25

NHPID name

Linum usitatissimum ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Linum usitatissimum ( USDA 2004 )

Common name(s)

Source material

Seed ( Blumenthal et al. 2000 )

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Dose(s):

1 Day per day

Directions for use:
  • Effects observed 12-24 hours after first dose, and may take 2-3 days.
  • For products providing doses that are ≥ 5 g per day, the following statement is required: For each dose, drink (or mix with) at least 150 ml of liquid. ( EMEA 2006 , ESCOP 2003 )
  • Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
  • For products providing doses that are ≥ 5 g per day, the following statement is required: Take 2 hours before or after taking other medications. ( Sweetman 2007 )
  • null;promote(s) bowel movement;constipation and/or irregularity: Take during the day (not immediately prior to bedtime). ( EMEA 2006 , ESCOP 2003 )

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s):

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Storage conditions

Specifications

References cited

References reviewed

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use